Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices 84149 

orphan@fda.hhs.gov; or by mailing the 

required information to the OOPD at the 

address found on our website. New 

users of the CDER NextGen Portal must 

register for an account. For designation 

requests submitted by email, the Agency 

recommends using automated read 

receipt to verify receipt of the email. 

Sponsors and others who plan to 

email information to FDA that is 

private, sensitive, proprietary, or 

commercial confidential are strongly 

encouraged to send it from an FDAsecured email address so the 

transmission is encrypted. The Agency 

will assume the addresses of emails 

received or email addresses provided as 

a point of contact are secure when 

responding to those email addresses. 

Sponsors and others can establish a 

secure email address link to FDA by 

sending a request to SecureEmail@

fda.hhs.gov. There may be a fee to a 

commercial enterprise for establishing a 

digital certificate before encrypted 

emails can be sent to FDA. 

Respondents to the information 

collection are sponsors who develop 

investigational drugs and biologicals for 

commercial use and who seek orphan 

drug designation, and upon approval or 

licensure, orphan drug exclusivity. 

In the Federal Register of June 13, 

2023 (88 FR 38513), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. 

Although we received one comment, it 

was not responsive to the information 

collection topics solicited and therefore 

is not addressed in this notice. 

We estimate the burden of this 

collection of information as follows 

based on data from 2022: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part or section; activity Number of 

respondents 

Number of 

records per 

recordkeeper 

Total 

annual 

records 

Average 

burden 

per record 

Total 

hours 

Part 316 associated records ................................................ 780 1.25 975 135 131,625 

§§ 316.20, 316.21, 316.26 (Form FDA 4035) ...................... 780 1.25 975 32 31,200 

§ 316.22; Notifications of changes in agents ....................... 300 1 300 0.5 150 

§ 316.24(a); Deficiency letters and granting orphan-drug 

designation ....................................................................... 20 1 20 2 40 

§ 316.27; Submissions to change ownership of orphandrug designation ............................................................... 90 1 90 3 270 

§ 316.30; Annual reports ...................................................... 2,039 1 2,039 3 6,117 

§ 316.36; Assurance of the availability of sufficient quantities of the orphan drug; holder’s consent for the approval of other marketing applications for the same drug 1 3 3 15 45 

Guidance Recommendations: Meeting requests to OOPD 

and related submission packages .................................... 807 1.5 1,211 4 4,842 

Total .............................................................................. ........................ ........................ 5,613 ........................ 174,289 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our burden estimate includes those 

activities related to: (1) requesting 

orphan drug designation; (2) responding 

to deficiencies letters with submissions 

of amendments; (3) keeping files current 

with contact information for agents and 

transfer of ownership, when applicable; 

(4) submitting annual reports while 

products have designation status; and 

(5) requesting and preparing for both 

informal and formal meetings. Because 

the PRA defines a recordkeeping 

requirement to include reporting those 

records to the Federal government, we 

account for these activities cumulatively 

in table 1 above. Upon a recent 

evaluation of the information collection, 

we adjusted our burden estimate to 

reflect an overall increase of 50,616 

hours and an increase of 766 records 

annually. We attribute this adjustment 

to an increase in the number of 

submissions, amendments, and annual 

reports. 

Dated: November 29, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26544 Filed 12–1–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: DATA 2000 

Waiver Training Payment Program 

Application for Payment, OMB No. 

0906–0061 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 2, 2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to the 

HRSA Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

DATA 2000 Waiver Training Payment 

Program Application for Payment, OMB 

No. 0906–0061—Revision. 

Abstract: The Substance Use— 

Disorder Prevention that Promotes 

Opioid Recovery and Treatment for 

Patients and Communities (SUPPORT) 

Act (Pub. L. 115–271), section 6083, 

amended the Social Security Act 

(subsections 1834(o)(3) and 1833(bb)), 


ddrumheller on DSK120RN23PROD with NOTICES1
84150 Federal Register / Vol. 88, No. 231 / Monday, December 4, 2023 / Notices 

authorizing the HHS Secretary to pay 

Federally Qualified Health Centers 

(FQHCs) and Rural Health Clinics 

(RHCs) for the average cost of training 

for purposes of receiving a DATA 2000 

waiver for their physicians and 

practitioners to furnish opioid use 

disorder treatment services. The 

SUPPORT Act made $6 million 

available to FQHCs and $2 million 

available to RHCs under the DATA 2000 

Waiver Training Payment Program. To 

receive payment, FQHCs and RHCs 

must submit an application in the 

manner specified by the Secretary. 

Authority to administer the DATA 2000 

program has been delegated to HRSA. 

Further information about the program 

can be found in the link below which 

provides guidance on the requirements 

of the DATA 2000 program and how 

qualified FQHCs and RHCs can apply to 

the program: https://help.hrsa.gov/ 

display/public/EHBSKBFG/ 

DATA+2000+Waiver+Training

+Payment+Program+FAQs. 

This purpose of this revision is to 

update the burden estimate for the RHC 

application process because the funding 

appropriated for FQHC DATA 2000 

payments has been fully expended. 

Therefore, no new applications for 

FQHC DATA 2000 payments can be 

accepted or approved. Only Medicare 

participating RHCs can apply for 

payments through the DATA 2000 

program, and pursuant to the 

authorizing statute and subsequent 

legislation eliminating the DATA 2000 

waiver requirement, such RHCs may 

only receive payments with respect to 

providers who first received their DATA 

2000 Waiver between January 1, 2019, 

and December 29, 2022. 

Applicant entities must provide 

information identifying the submitting 

organization and the number of 

practitioners who have completed 

training and obtained a DATA 2000 

waiver. The form will also require the 

entity to include information regarding 

each claimed practitioner’s name, 

practitioner type (e.g., physician, 

physician assistant, nurse practitioner, 

certified nurse midwife, clinical nurse 

specialist, certified registered nurse, or 

anesthetist), National Provider Identifier 

number, Drug Enforcement 

Administration number, state license 

number, length of training, date the 

training was completed, date of waiver 

attainment, and DATA 2000 waiver 

number. Additionally, the form will 

require signature of an attestation 

statement certifying that: (1) each 

practitioner for which the entity is 

seeking payment under the application 

is employed by or working under 

contract for the applicant health facility; 

(2) it is the first time the entity is 

seeking payment on behalf of the listed 

practitioner(s); (3) the entity is eligible 

to seek payment under 42 U.S.C. 

1395m(o)(3) or 42 U.S.C. 1395l(bb); (4) 

each practitioner is furnishing opioid 

use disorder treatment services; and (5) 

the statements herein are true, complete, 

and accurate to the best of the 

applicant’s knowledge. 

Need and Proposed Use of the 

Information: The Substance Use— 

Disorder Prevention that Promotes 

Opioid Recovery and Treatment for 

Patients and Communities Act requires 

RHCs to submit to the Secretary an 

application for payment at such time, in 

such manner, and containing such 

information as specified by the 

Secretary in order to receive a payment 

under section 6083. This form will 

allow RHCs to apply for such payments 

based on the average cost of training to 

obtain DATA 2000 waivers, as 

determined by the Secretary, for their 

physicians and practitioners to furnish 

opioid use disorder treatment services. 

The form will also provide HRSA with 

the requisite data to validate qualifying 

DATA 2000 waiver possessions for the 

purpose of ensuring accurate payments 

to RHCs. 

Likely Respondents: Only Medicare 

participating RHCs are eligible to apply. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

DATA 2000 Waiver Training Payment Program Application for Payment ........... 300 1 300 0.5 150.0 

Total ............................................................................................................... 300 1 300 ........................ 150.0 

HRSA specifically requests comments 

on: (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–26554 Filed 12–1–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

National Urban Indian Behavioral 

Health Awareness 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2024–IHS–NUIBH–0001. 

Assistance Listing (Catalog of Federal 

Domestic Assistance or CFDA) Number: 

93.654. 


ddrumheller on DSK120RN23PROD with NOTICES1